United States - English - NLM (National Library of Medicine)
ERYTHROMYCIN- erythromycin tablet, film coated
Avera McKennan Hospital
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin
Tablets and other antibacterial drugs, Erythromycin Tablets should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by bacteria.
Erythromycin Tablets, USP are an antibacterial product containing erythromycin, USP, in a unique,
nonenteric film coating for oral administration. Erythromycin Tablets are available in two strengths
containing either 250 mg or 500 mg of erythromycin base.
Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus)
and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids.
Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol,
chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*,
12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-??-L-ribo-hexopyranosyl)oxy]-14-ethyl-
hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C
H NO , and the
molecular weight is 733.94. The structural formula is:
Colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C Red No. 30 Aluminum Lake,
hydroxypropyl cellulose, hypromellose, hydroxypropyl methylcellulose phthalate, magnesium stearate,
microcrystalline cellulose, povidone, polyethylene glycol, propylene glycol, sodium citrate, sodium
hydroxide, sorbic acid, sorbitan monooleate, talc, and titanium dioxide.
Orally administered erythromycin base and its salts are readily absorbed in the microbiologically active
form. Interindividual variations in the absorption of erythromycin are, however, observed, and some
patients do not achieve optimal serum levels. Erythromycin is largely bound to plasma proteins. After
absorption, erythromycin diffuses readily into most body fluids. In the absence of meningeal
inflammation, low concentrations are normally achieved in the spinal fluid but the passage of the drug
across the blood-brain barrier increases in meningitis. Erythromycin crosses the placental barrier, but
fetal plasma levels are low. The drug is excreted in human milk. Erythromycin is not removed by
peritoneal dialysis or hemodialysis.
In the presence of normal hepatic function, erythromycin is concentrated in the liver and is excreted in
the bile; the effect of hepatic dysfunction on biliary excretion of erythromycin is not known. After oral
administration, less than 5% of the administered dose can be recovered in the active form in the urine.
Optimal blood levels are obtained when Erythromycin Tablets are given in the fasting state (at least 1/2
hour and preferably 2 hours before meals). Bioavailability data are available from Arbor
Mechanism of Action
Erythromycin acts by inhibition of protein synthesis by binding 50S ribosomal subunits of susceptible
organisms. It does not affect nucleic acid synthesis.
Mechanism of Resistance
The major route of resistance is modification of the 23S rNA in the 50S ribosomal subunit to
insensitivity while efflux can also be significant.
Interactions with Other Antibiotics
Antagonism exists in vitro between erythromycin and clindamycin, lincomycin, and chloramphenicol.
Erythromycin has been shown to be active against most isolates of the following bacteria both in vitro
and in clinical infections as described in the INDICATIONS AND USAGE section.
Staphylococcus aureus (resistant organisms may emerge during treatment)
The following in vitro data are available, but their clinical significance is unknown.
At least 90% of the following bacteria exhibit in vitro minimum inhibitory concentration (MIC) less than
or equal to the susceptible breakpoint for erythromycin. However, the efficacy of erythromycin in
treating clinical infections due to these bacteria has not been established in adequate and well controlled
Viridans group streptococci
Susceptibility Test Methods
When available the clinical microbiology laboratory should provide the results of in vitro susceptibility
test results for antimicrobial drug products used in resident hospitals to the physician as periodic
reports that describe the susceptibility profile of nosocomial and community-acquired pathogens.
These reports should aid the physician in selecting an antibacterial drug product for treatment.
Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MIC's).
These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs
should be determined using a standardized test method
(broth and/or agar). The MIC values should be
interpreted according to criteria provided in Table 1.
Quantitative methods that require measurement of zone diameters can also provide reproducible
estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size provides an
estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be
determined using a standardized test method.
This procedure uses paper disks impregnated with 15
mcg erythromycin to test the susceptibility of microorganisms to erythromycin. The disc diffusion
interpretive criteria are provided in Table 1.
Table 1. In Vitro Susceptibility Test Interpretive Criteria for
(zone diameters in mm)
A report of "Susceptible" indicates that the antimicrobial is likely to inhibit growth of the pathogen if
the antimicrobial compound reaches the concentrations at the site of infection necessary to inhibit
growth of the pathogen. A report of "Intermediate" indicates that the result should be considered
equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the
test should be repeated. This category implies possible clinical applicability in body sites where the
drug product is physiologically concentrated or in situations where high dosage of drug can be used.
This category also provides a buffer zone which prevents small uncontrolled technical factors from
causing major discrepancies in interpretation. A report of "Resistant" indicates that the antimicrobial is
not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations
usually achievable at the infection site; other therapy should be selected.
Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure
the accuracy and precision of supplies and reagents used in the assay, and the techniques of the
individuals performing the test.
Standard erythromycin powder should provide the following
range of MIC values noted in Table 2. For the diffusion technique using the 15 mcg disk, the criteria in
Table 2 should be achieved.
Table 2. Acceptable Quality Control Ranges for Erythromycin
(zone diameters in
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin
Tablets, USP and other antibacterial drugs, Erythromycin Tablets, USP should be used only to treat or
prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When
culture and susceptibility information are available, they should be considered in selecting or modifying
antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may
contribute to the empiric selection of therapy.
Erythromycin Tablets, USP are indicated in the treatment of infections caused by susceptible strains of
the designated microorganisms in the diseases listed below:
Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes;
Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of
sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations
ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.)
Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or
Listeriosis caused by Listeria monocytogenes.
Respiratory tract infections due to Mycoplasma pneumoniae.
Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or
Staphylococcus aureus (resistant staphylococci may emerge during treatment).
Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the
1, 2, 3, 4
organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical
studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible
Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent
establishment of carriers and to eradicate the organism in carriers.
Erythrasma: In the treatment of infections due to Corynebacterium minutissimum.
Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis
requires treatment with other agents.
Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin
(erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative
drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with
a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving
erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months.
Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis:
conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When
tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of
uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis.
When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of
nongonococcal urethritis caused by Ureaplasma urealyticum.
Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice
of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis,
spinal fluid should be examined before treatment and as part of the follow-up after therapy.
Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy
studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may
be effective in treating Legionnaires' Disease.
Prevention of Initial Attacks of Rheumatic Fever
Penicillin is considered by the American Heart Association to be the drug of choice in the prevention
of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper
respiratory tract e.g., tonsillitis, or pharyngitis).
Erythromycin is indicated for the treatment of
penicillin-allergic patients. The therapeutic dose should be administered for ten days.
Prevention of Recurrent Attacks of Rheumatic Fever
Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice
in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and
sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term
prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).
Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic.
Erythromycin is contraindicated in patients taking terfenadine, astemizole, cisapride, pimozide,
ergotamine, or dihydroergotamine. (See PRECAUTIONS - Drug Interactions.)
There have been reports of hepatic dysfunction, including increased liver enzymes, and hepatocellular
and/or cholestatic hepatitis, with or without jaundice, occurring in patients receiving oral erythromycin
Erythromycin has been associated with prolongation of the QT interval and infrequent cases of
arrhythmia. Cases of torsades de pointes have been spontaneously reported during postmarketing
surveillance in patients receiving erythromycin. Fatalities have been reported. Erythromycin should be
avoided in patients with known prolongation of the QT interval, patients with ongoing proarrhythmic
conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and
in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol)
antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT
Syphilis in Pregnancy
There have been reports suggesting that erythromycin does not reach the fetus in adequate
concentration to prevent congenital syphilis. Infants born to women treated during pregnancy with oral
erythromycin for early syphilis should be treated with an appropriate penicillin regimen.
Clostridium difficile Associated Diarrhea
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial
agents, including Erythromycin Tablets, and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin
producing strains of C. difficile cause increased morbidity and mortality, as these infections can be
refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients
who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD
has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to
be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic
treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Serious adverse reactions have been reported in patients taking erythromycin concomitantly with
CYP3A4 substrates. These include colchicine toxicity with colchicine; rhabdomyolysis with
simvastatin, lovastatin, and atorvastatin; and hypotension with calcium channel blockers metabolized by
CYP3A4 (e.g., verapamil, amlodipine, diltiazem) (see PRECAUTIONS - Drug Interactions).
There have been post-marketing reports of colchicine toxicity with concomitant use of erythromycin
and colchicine. This interaction is potentially life-threatening, and may occur while using both drugs at
their recommended doses (see PRECAUTIONS - Drug Interactions).
Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving
erythromycin concomitantly with lovastatin. Therefore, patients receiving concomitant lovastatin and
erythromycin should be carefully monitored for creatine kinase (CK) and serum transaminase levels.
(See package insert for lovastatin.)
Prescribing Erythromycin Tablets in the absence of a proven or strongly suspected bacterial infection
or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the
development of drug-resistant bacteria.
Since erythromycin is principally excreted by the liver, caution should be exercised when erythromycin
is administered to patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY and
Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome has
been reported in patients receiving erythromycin therapy.
There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants
following erythromycin therapy. In one cohort of 157 newborns who were given erythromycin for
pertussis prophylaxis, seven neonates (5%) developed symptoms of non-bilious vomiting or irritability
with feeding and were subsequently diagnosed as having IHPS requiring surgical pyloromyotomy. A
possible dose-response effect was described with an absolute risk of IHPS of 5.1% for infants who
took erythromycin for 8 to 14 days and 10% for infants who took erythromycin for 15 to 21 days.
erythromycin may be used in the treatment of conditions in infants which are associated with significant
mortality or morbidity (such as pertussis or neonatal Chlamydia trachomatis infections), the benefit of
erythromycin therapy needs to be weighed against the potential risk of developing IHPS. Parents should
be informed to contact their physician if vomiting or irritability with feeding occurs.
Prolonged or repeated use of erythromycin may result in an overgrowth of nonsusceptible bacteria or
fungi. If superinfection occurs, erythromycin should be discontinued and appropriate therapy instituted.
When indicated, incision and drainage or other surgical procedures should be performed in conjunction
with antibiotic therapy.
Observational studies in humans have reported cardiovascular malformations after exposure to drug
products containing erythromycin during early pregnancy.
Information for Patients
Patients should be counseled that antibacterial drugs including Erythromycin Tablets should only be
used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When
Erythromycin Tablets are prescribed to treat a bacterial infection, patients should be told that although it
is common to feel better early in the course of therapy, the medication should be taken exactly as
directed. Skipping doses or not completing the full course of therapy may (1) decrease the
effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop
resistance and will not be treatable by Erythromycin Tablets or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is
discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody
stools (with or without stomach cramps and fever) even as late as two or more months after having taken
the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Erythromycin use in patients who are receiving high doses of theophylline may be associated with an
increase in serum theophylline levels and potential theophylline toxicity. In case of theophylline
toxicity and/or elevated serum theophylline levels, the dose of theophylline should be reduced while
the patient is receiving concomitant erythromycin therapy.
There have been published reports suggesting that when oral erythromycin is given concurrently with
theophylline there is a decrease in erythromycin serum concentrations of approximately 35%. The
mechanism by which this interaction occurs is unknown. The decrease in erythromycin concentrations
due to co-administration of theophylline could result in subtherapeutic concentrations of erythromycin.
Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent
verapamil, belonging to the calcium channel blockers drug class.
Concomitant administration of erythromycin and digoxin has been reported to result in elevated digoxin
There have been reports of increased anticoagulant effects when erythromycin and oral anticoagulants
were used concomitantly. Increased anticoagulation effects due to interactions of erythromycin with
oral anticoagulants may be more pronounced in the elderly.
Erythromycin is a substrate and inhibitor of the 3A isoform subfamily of the cytochrome p450 enzyme
system (CYP3A). Coadministration of erythromycin and a drug primarily metabolized by CYP3A may be
associated with elevations in drug concentrations that could increase or prolong both the therapeutic
and adverse effects of the concomitant drug. Dosage adjustments may be considered, and when possible,
serum concentrations of drugs primarily metabolized by CYP3A should be monitored closely in patients
concurrently receiving erythromycin.
The following are examples of some clinically significant CYP3A based drug interactions. Interactions
with other drugs metabolized by the CYP3A isoform are also possible. The following CYP3A based
drug interactions have been observed with erythromycin products in post-marketing experience:
In addition, there have been reports of interactions of erythromycin with drugs not thought to be
metabolized by CYP3A, including hexobarbital, phenytoin, and valproate.
Erythromycin has been reported to significantly alter the metabolism of the nonsedating antihistamines
terfenadine and astemizole when taken concomitantly. Rare cases of serious cardiovascular adverse
events, including electrocardiographic QT/QT interval prolongation, cardiac arrest, torsades de
pointes, and other ventricular arrhythmias, have been observed. (See CONTRAINDICATIONS.) In
addition, deaths have been reported rarely with concomitant administration of terfenadine and
Post-marketing reports indicate that co-administration of erythromycin with ergotamine or
dihydroergotamine has been associated with acute ergot toxicity characterized by vasospasm and
ischemia of the extremities and other tissues including the central nervous system. Concomitant
administration of erythromycin with ergotamine or dihydroergotamine is contraindicated (see
Triazolobenzodiazepines (such as triazolam and alprazolam) and related benzodiazepines
Erythromycin has been reported to decrease the clearance of triazolam and midazolam, and thus,
may increase the pharmacologic effect of these benzodiazepines.
HMG-CoA Reductase Inhibitors
Erythromycin has been reported to increase concentrations of HMG-CoA reductase inhibitors
(e.g., lovastatin and simvastatin). Rare reports of rhabdomyolysis have been reported in patients
taking these drugs concomitantly.
Erythromycin has been reported to increase the systemic exposure (AUC) of sildenafil. Reduction
of sildenafil dosage should be considered. (See Viagra package insert.)
There have been spontaneous or published reports of CYP3A based interactions of erythromycin
with cyclosporine, carbamazepine, tacrolimus, alfentanil, disopyramide, rifabutin, quinidine,
methyl-prednisolone, cilostazol, vinblastine, and bromocriptine.
Concomitant administration of erythromycin with cisapride, pimozide, astemizole, or terfenadine is
contraindicated. (See CONTRAINDICATIONS.)
There have been post-marketing reports of drug interactions when erythromycin was co-administered
with cisapride, resulting in QT prolongation, cardiac arrhythmias, ventricular tachycardia, ventricular
fibrillation, and torsades de pointes, most likely due to the inhibition of hepatic metabolism of cisapride
by erythromycin. Fatalities have been reported. (See CONTRAINDICATIONS).
Colchicine is a substrate for both CYP3A4 and the efflux transporter P-glycoprotein (P-gp).
Erythromycin is considered a moderate inhibitor of CYP3A4. A significant increase in colchicine
plasma concentration is anticipated when co-administered with moderate CYP3A4 inhibitors such as
erythromycin. If co-administration of colchicine and erythromycin is necessary, the starting dose of
colchicine may need to be reduced, and the maximum colchicine dose should be lowered. Patients
should be monitored for clinical symptoms of colchicine toxicity (see WARNINGS).
Drug/Laboratory Test Interactions
Erythromycin interferes with the fluorometric determination of urinary catecholamines.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term oral dietary studies conducted with erythromycin stearate in rats up to 400 mg/kg/day and in
mice up to about 500 mg/kg/day (approximately 1 to 2 fold of the maximum human dose on a body
surface area basis) did not provide evidence of tumorigenicity. Erythromycin stearate did not show
genotoxic potential in the Ames, and mouse lymphoma assays or induce chromosomal aberrations in
CHO cells. There was no apparent effect on male or female fertility in rats treated with erythromycin
base by oral gavage at 700 mg/kg/day (approximately 3 times the maximum human dose on a body
surface area basis).
Pregnancy Category B
There is no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed
erythromycin base by oral gavage at 350 mg/kg/day (approximately twice the maximum recommended
human dose on a body surface area) prior to and during mating, during gestation, and through weaning.
No evidence of teratogenicity or embryotoxicity was observed when erythromycin base was given by
oral gavage to pregnant rats and mice at 700 mg/kg/day and to pregnant rabbits at 125 mg/kg/day
(approximately 1 to 3 times the maximum recommended human dose).
Labor and Delivery
The effect of erythromycin on labor and delivery is unknown.
Erythromycin is excreted in human milk. Caution should be exercised when erythromycin is
administered to a nursing woman.
See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.
Elderly patients, particularly those with reduced renal or hepatic function, may be at increased risk for
developing erythromycin-induced hearing loss. (See ADVERSE REACTIONS and DOSAGE AND
Elderly patients may be more susceptible to development of torsades de pointes arrhythmias than
younger patients. (See WARNINGS.)
Elderly patients may experience increased effects of oral anticoagulant therapy while undergoing
treatment with erythromycin. (See PRECAUTIONS - Drug Interactions).
Erythromycin Tablets (250 mg) contain 8.5 mg (0.4 mEq) of sodium per tablet.
Erythromycin Tablets (500 mg) contain 17 mg (0.7 mEq) of sodium per tablet.
The geriatric population may respond with a blunted natriuresis to salt loading. This may be clinically
important with regard to such diseases as congestive heart failure.
The most frequent side effects of oral erythromycin preparations are gastrointestinal and are dose-
related. They include nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatitis,
hepatic dysfunction and/or abnormal liver function test results may occur. (See WARNINGS.)
Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. (See
Erythromycin has been associated with QT prolongation and ventricular arrhythmias, including
ventricular tachycardia and torsades de pointes. (See WARNINGS.)
Allergic reactions ranging from urticaria to anaphylaxis have occurred. Skin reactions ranging from
mild eruptions to erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have
been reported rarely.
There have been reports of interstitial nephritis coincident with erythromycin use.
There have been rare reports of pancreatitis and convulsions.
There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal
insufficiency and in patients receiving high doses of erythromycin.
In case of overdosage, erythromycin should be discontinued. Overdosage should be handled with the
prompt elimination of unabsorbed drug and all other appropriate measures should be instituted.
Erythromycin is not removed by peritoneal dialysis or hemodialysis.
DOSAGE AND ADMINISTRATION
In most patients, Erythromycin Tablets are well absorbed and may be dosed orally without regard to
meals. However, optimal blood levels are obtained when Erythromycin Tablets are given in the fasting
state (at least 1/2 hour and preferably 2 hours before meals).
The usual dosage of Erythromycin Tablets is one 250 mg tablet four times daily in equally spaced
doses or one 500 mg tablet every 12 hours. Dosage may be increased up to 4 g per day according to the
severity of the infection. However, twice-a-day dosing is not recommended when doses larger than 1 g
daily are administered.
Age, weight, and severity of the infection are important factors in determining the proper dosage. The
usual dosage is 30 to 50 mg/kg/day, in equally divided doses. For more severe infections this dosage
may be doubled but should not exceed 4 g per day.
In the treatment of streptococcal infections of the upper respiratory tract (e.g., tonsillitis or pharyngitis),
the therapeutic dosage of erythromycin should be administered for at least ten days.
The American Heart Association suggests a dosage of 250 mg of erythromycin orally, twice a day in
long-term prophylaxis of streptococcal upper respiratory tract infections for the prevention of
recurring attacks of rheumatic fever in patients allergic to penicillin and sulfonamides.
Conjunctivitis of the Newborn Caused by Chlamydia trachomatis
Oral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 2 weeks.
Pneumonia of Infancy Caused by Chlamydia trachomatis
Although the optimal duration of therapy has not been established, the recommended therapy is oral
erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 3 weeks.
Urogenital Infections During Pregnancy Due to Chlamydia trachomatis
Although the optimal dose and duration of therapy have not been established, the suggested treatment is
500 mg of erythromycin by mouth four times a day on an empty stomach for at least 7 days. For women
who cannot tolerate this regimen, a decreased dose of one erythromycin 500 mg tablet orally every 12
hours or 250 mg by mouth four times a day should be used for at least 14 days.
For adults with uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia
trachomatis, when tetracycline is contraindicated or not tolerated
500 mg of erythromycin by mouth four times a day for at least 7 days.
For patients with nongonococcal urethritis caused by Ureaplasma urealyticum when tetracycline
is contraindicated or not tolerated
500 mg of erythromycin by mouth four times a day for at least seven days.
30 to 40 g given in divided doses over a period of 10 to 15 days.
Acute Pelvic Inflammatory Disease Caused by N. gonorrhoeae
500 mg Erythrocin
Lactobionate-I.V. (erythromycin lactobionate for injection, USP) every 6 hours for
3 days, followed by 500 mg of erythromycin base orally every 12 hours for 7 days.
500 mg every 12 hours or 250 mg every 6 hours for 10 to 14 days.
30 to 50 mg/kg/day in divided doses for 10 to 14 days.
Pertus s is
Although optimal dosage and duration have not been established, doses of erythromycin utilized in
reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.
Although optimal dosage has not been established, doses utilized in reported clinical data were 1 to 4 g
daily in divided doses.
Erythromycin Tablets are supplied as pink, unscored oval tablets in the following strengths and
NDC 69189-0112-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital
250 mg tablets (debossed
Bottles of 100
Store below 86??F (30??C).
1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility
Tests for Bacteria that Grow Aerobically, Approved Standard ??? Ninth Edition. CLSI document M07-
A9, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne,
Pennsylvania 19087, USA, 2012.
2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial
Susceptibility Testing: Twenty-third Informational Supplement. CLSI document M100-S23, Clinical and
Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087,
3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk
Diffusion Susceptibility Tests; Approved Standard ??? Eleventh Edition CLSI document M02-A11.
Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania
19087, USA, 2012.
4. Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of the Council on
Cardiovascular Disease in the Young, the American Heart Association: Prevention of Rheumatic
Fever. Circulation. 78(4):1082-1086, October 1988.
5. Honein, M.A., et. al.: Infantile hypertrophic pyloric stenosis after pertussis prophylaxis with
erythromycin: a case review and cohort study. The Lancet 1999:354 (9196): 2101-5.
6. Data on file, Arbor Pharmaceuticals, LLC.
03-A922-R2 Revised: July, 2013
Arbor Pharmaceuticals, LLC
Atlanta, GA 30328
(Nos. 6326 and 6227)
PRINCIPAL DISPLAY PANEL - 250 mg label
erythromycin tablet, film coated
Product T ype
HUMAN PRESCRIPTION DRUG
Ite m Code (Source )
NDC:6 9 18 9 -0 112(NDC:24338 -10 2)
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
Erythro mycin (UNII: 6 39 37KV33D) (Erythro mycin - UNII:6 39 37KV33D)
Erythro myc in
Stre ng th
Silico n Dio xide (UNII: ETJ7Z6 XBU4)
cro sca rmello se so dium (UNII: M28 OL1HH48 )
cro spo vido ne (UNII: 6 8 40 19 6 0 MK)
D&C Red No . 3 0 (UNII: 2S42T28 0 8 B)
a luminum o xide (UNII: LMI26 O6 9 33)
hydro xypro pyl cellulo se ( type H) (UNII: RFW2ET6 71P)
hypro mello ses (UNII: 3NXW29 V3WO)
hypro mello se phtha la te ( 2 4 % phtha la te, 55 CST) (UNII: 8 7Y6 436 BKR)
ma g nesium stea ra te (UNII: 70 0 9 7M6 I30 )
cellulo se, micro crysta lline (UNII: OP1R32D6 1U)
po vido nes (UNII: FZ9 8 9 GH9 4E)
po lyethylene g lyco ls (UNII: 3WJQ0 SDW1A)
Avera McKennan Hospital
po lyethylene g lyco ls (UNII: 3WJQ0 SDW1A)
pro pylene g lyco l (UNII: 6 DC9 Q16 7V3)
so dium citra te (UNII: 1Q73Q2JULR)
so dium hydro xide (UNII: 55X0 4QC32I)
so rbic a cid (UNII: X0 45WJ9 8 9 B)
so rbita n mo no o lea te (UNII: 0 6 XEA2VD56 )
ta lc (UNII: 7SEV7J4R1U)
tita nium dio xide (UNII: 15FIX9 V2JP)
no sco re
S hap e
S iz e
Marketing Start Date
Marketing End Date
NDC:6 9 18 9 -0 112-1
1 in 1 DOSE PACK; Type 0 : No t a Co mbinatio n Pro duct
Marke ting Cate gory
Application Numbe r or Monograph Citation
Marke ting Start Date
Marke ting End Date
ANDA0 6 16 21
0 3/0 1/20 15
Avera McKennan Hospital (068647668)
Ad d re s s
Busine ss Ope rations
Avera McKennan Ho spital
0 6 8 6 476 6 8
relabel(6 9 18 9 -0 112) , repack(6 9 18 9 -0 112)